Upper Gwynedd Township, Pennsylvania, United States
Hybrid
Not Available
Job Description
Join our team as a Specialists in Clinical Data Management to support our clinical studies.
In this role, as a Clinical Data Management Specialist, you'll assumes the responsibilities for all clinical programming (including reporting and analytics) deliverables including Oracle, Veeva platforms along with the external data captured in support of the clinical studies.
Primary activities include, but are not limited to:
Coordinates and participates in the following activities:
Design, build, maintain, test, and document data review based on written specifications established by Global Clinical Data Management, Clinical Research and Global Safety.
Review the technical feasibility of study team proposed programming/reporting and technically implement them. Work effectively among teams to communicate issues and ideas to improve business along with understanding of Protocol.
Support the development & reporting for data cleaning, medical review, clinical monitoring, and safety reports for quality and timely availability in support of our customer needs.
Perform ongoing support for In-Life Reports.
Change Requests and Incident Reports are fully documented, signed off, tracked, and reported to upper management.
Participate in extra activities including, but not limited to, study improvement task forces, automation, initiatives, testing of new systems, and ongoing training and mentoring.
Education:
Associate degree with a minimum of 3 years’ experience working in clinical data programming, data engineering, or related data-management/clinical operations functions OR
Bachelor's Degree with a minimum of 2 years’ experience working in in clinical data programming, data engineering, or related data-management/clinical operations functions OR
Advanced Degree (master’s or doctorate) with prior experience in clinical development and / or clinical data programming, data engineering, or related data-management/clinical operations activities preferred.
Required Knowledge and Skills:
Strong technical proficiency in Clinical Data Management/Reporting Systems like Databricks, Python, SAS, SQL/PL SQL, Power BI, etc along with AI related tools.
Solid knowledge of MS Windows/Office software and exposure to web-based applications.
Solid knowledge of System Development Lifecycle Management / system validation knowledge.
Ability to establish and maintain good working relationships with different functional areas.
Strong sense of urgency and customer focus.
Excellent communication skills and interacts effectively with Study Team.
Strong organizational and problem-solving skills.
Desire and ability to learn new processes and technologies.
Ability to multi-task, work independently, and good communication skills.
Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH.
#eligibleforERP
#clinicaltrialjobs
#GDMS
Required Skills:
Clinical Data Management, Communication, Computer Programming, Data Analysis, Data Management, Data Quality Assurance, Electronic Data Capture (EDC), PL/SQL (Programming Language), SQL Databases, Team CommunicationPreferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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The salary range for this role is
$87,300.00 - $137,400.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
09/14/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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